Molecular Analysis of Suspected or High-Risk Lung Cancer to Drive Individualized Care (Interception for Suspected Lung Cancer)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-06-24

Study Completion Date

2027-07-01

Brief Summary

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This study evaluates the effectiveness of robotic biopsies in providing information about hereditary or cancer specific genetic variants that may have a role in diagnosis of cancer and to develop genetic results and medical record databank for future studies.

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Detailed Description

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PRIMARY OBJECTIVES:

I. Assessing whether the percentage of samples adequate for WES (Whole Exome Sequencing)/WT (Wild-Type) sequencing is at least 80%.

II. Development of a data bank of WES/WT and germline sequencing data for future analyses.

OUTLINE: This is an observational study.

Patients receive genomic counseling and genomic testing education, undergo blood or saliva collection, provide previously collected tissue sample and have medical records reviewed on study. Patients and healthcare providers receive results of any genetic variants found on testing.

Conditions

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Lung Carcinoma Metastatic Malignant Neoplasm in the Lung

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Observational

Patients receive genomic counseling and genomic testing education, undergo blood or saliva collection, provide previously collected tissue sample and have medical records reviewed on study. Patients and healthcare providers receive results of any genetic variants found on testing.

Non-Interventional Study

Intervention Type OTHER

Non-interventional study

Interventions

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Non-Interventional Study

Non-interventional study

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Subject age 18 years and older
* Subject is scheduled/was scheduled for a bronchoscopy as part of standard of care
* Subject with a moderate to high risk of lung cancer based on clinical demographic and radiologic information or with suspected metastatic disease
* Ability to provide blood or saliva sample
* Ability to provide archived tissue
* Subject is able to understand and adhere to study requirements and able to provide informed consent

Exclusion Criteria

* Individuals who have situations that would limit compliance with the study requirements
* Institutionalized (i.e. federal medical prison)
* Pregnant
* Prior germline genetic testing with a 40+ multi-gene panel within the last 1 year of enrollment
* Prior somatic tissue (250+ gene) testing within the prior 3 months of enrollment

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No